Merck’s new pneumococcal vaccine.
Courtesy of Merck
The Food and Drug Administration on Monday MerckThe new vaccine is designed to protect adults against a bacteria called pneumococcus, which can cause serious illness and a lung infection called pneumonia, according to the drug company.
Merck’s vaccine, called Capvaxiv, specifically protects against 21 strains of the bacteria to prevent severe pneumococcal disease that can spread to other parts of the body and cause pneumonia. The company says it is the first pneumococcal conjugate vaccine designed specifically for adults, and aims to offer broader protection than vaccines currently on the market.
Healthy adults can contract pneumococcal infections, but older patients and those with chronic or immunocompromised conditions are at increased risk of developing particularly severe, so-called “invasive” infections.
Invasive pneumococcal infections can cause meningitis, which causes inflammation in the areas around the brain and spinal cord, or a bloodstream infection called bacteremia.
“People with chronic lung disease, even asthma, are at higher risk for getting pneumococcal infections, being hospitalized and losing work,” Heather Pratt, product development team leader at Merck & Co. for the newly approved vaccine, told CNBC in an interview. “These are things that really impact the quality of life for adults and children.”
About 150,000 adults are hospitalized with pneumococcal pneumonia each year in the U.S., Pratt said, and most deaths from more severe forms of pneumonia occur in adults over 50, Merck said in a December statement.
Even after FDA approval, the company’s one-dose vaccine has yet to reach patients, and an advisory committee to the Centers for Disease Control and Prevention is scheduled to meet June 27 to discuss who should be eligible for the vaccine.
Pratt said Merck supports the committee’s decision and is ready to supply vaccines by the end of the summer.
Merck’s Competitive Advantages
Some analysts see capvaxib as a key growth engine for Merck as it prepares to make up for losses from its blockbuster cancer drug Keytruda, which loses U.S. sales exclusivity in 2028.
The market for pneumococcal conjugate vaccines is currently worth about $7 billion and could grow to more than $10 billion over the next few years, according to a November report by analysts at Cantor Fitzgerald.
Merck’s newly approved vaccine could give pharmaceutical companies, including other companies, a competitive edge in that field. PfizerMerck currently markets two pneumococcal vaccines, but neither has been specifically developed for adults: its existing vaccine, Vaxneuvance, for example, is approved in the United States for patients 6 weeks of age or older.
Pfizer’s single-dose pneumococcal vaccine, Prevnar 20, currently dominates the adult market, but Merck expects the new vaccine to capture the lion’s share of the adult market, Pratt said.
“We expect to see rapid uptake of capvaxiv,” she said, adding that the company is confident the data on the vaccine will “resonate strongly” with clinicians and policymakers.
Merck’s pneumococcal vaccine protects against eight strains not included in other approved vaccines against the disease. These eight strains account for approximately 30% of invasive pneumococcal disease cases in patients aged 65 and older, according to CDC data from 2018 to 2021 released by Merck.
Citing CDC data, Merck said the 21 strains in its vaccine account for about 85% of invasive pneumococcal disease cases in adults over 65. Meanwhile, Pfizer’s Prevnar targets only the strains that account for about 51% of cases in that age group, according to the same CDC data.
The FDA’s approval was based in part on results from a late-stage trial called STRIDE-3, which compared Merck’s vaccine with Pfizer’s Prevnar 20 in adults 18 and older who had never received a pneumococcal vaccine.
Correction: This story has been updated to reflect that 150,000 U.S. adults are hospitalized with pneumococcal pneumonia each year.
